Radiotherapy & Oncology
Volume 95, Issue 3 , Pages 292-297 , June 2010

Multicentre phase I–II trial of capecitabine and oxaliplatin in combination with radiotherapy for unresectable pancreatic and biliary tract cancer: The CORGI-U study

  • Adalsteinn Gunnlaugsson

      Affiliations

    • Department of Oncology; and
    • Corresponding Author InformationCorresponding author. Address: Department of Oncology, Lund University Hospital, Lund 22185, Sweden.
  • ,
  • Harald Anderson

      Affiliations

    • Department of Cancer Epidemiology, Lund University, Sweden
  • ,
  • Pehr Lind

      Affiliations

    • Departments of Oncology and Pathology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden
  • ,
  • Bengt Glimelius

      Affiliations

    • Departments of Oncology and Pathology, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden
    • Departments of Oncology, Radiology and Clinical Immunology, Akademiska Hospital, Uppsala University, Sweden
  • ,
  • Anders Johnsson

      Affiliations

    • Department of Oncology; and

Received 23 November 2009 ,Revised 10 March 2010 ,Accepted 5 April 2010.

References 

  1. Sultana A, Tudur Smith C, Cunningham D, et al. Systematic review, including meta-analyses, on the management of locally advanced pancreatic cancer using radiation/combined modality therapy. Br J Cancer. 2007;96:1183–1190
  2. Baisden JM, Kahaleh M, Weiss GR, et al. Multimodality treatment with helical tomotherapy intensity modulated radiotherapy, capecitabine, and photodynamic therapy is feasible and well tolerated in patients with hilar cholangiocarcinoma. Gastrointest Cancer Res. 2008;2:219–224
  3. Ben-David MA, Griffith KA, Abu-Isa E, et al. External-beam radiotherapy for localized extrahepatic cholangiocarcinoma. Int J Radiat Oncol Biol Phys. 2006;66:772–779
  4. Kjellstrom J, Kjellen E, Johnsson A. In vitro radiosensitization by oxaliplatin and 5-fluorouracil in a human colon cancer cell line. Acta Oncol. 2005;44:687–693
  5. Gunnlaugsson A, Anderson H, Fernebro E, et al. Multicentre phase II trial of capecitabine and oxaliplatin in combination with radiotherapy for unresectable colorectal cancer: The CORGI-L study. Eur J Cancer. 2009;45:807–813
  6. Rodel C, Liersch T, Hermann RM, et al. Multicenter phase II trial of chemoradiation with oxaliplatin for rectal cancer. J Clin Oncol. 2007;25:110–117
  7. Machiels JP, Duck L, Honhon B, et al. Phase II study of preoperative oxaliplatin, capecitabine and external beam radiotherapy in patients with rectal cancer: the RadiOxCape study. Ann Oncol. 2005;16:1898–1905
  8. Xiong HQ, Varadhachary GR, Blais JC, et al. Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer. 2008;113:2046–2052
  9. Nehls O, Oettle H, Hartmann JT, et al. Capecitabine plus oxaliplatin as first-line treatment in patients with advanced biliary system adenocarcinoma: a prospective multicentre phase II trial. Br J Cancer. 2008;98:309–315
  10. Trotti A, Byhardt R, Stetz J, et al. Common toxicity criteria: version 2.0. An improved reference for grading the acute effects of cancer treatment: impact on radiotherapy. Int J Radiat Oncol Biol Phys. 2000;47:13–47
  11. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumours. J Natl Cancer Inst. 2000;92:205–216
  12. Kalbfleisch JD, Prentice RL. In: The statistical analysis of failure time data. New York: John Wiley and Sons; 1980;
  13. Saif M, Black G, Shalija R, et al. Phase II study of capecitabine with concomitant radiotherapy for patients with locally advanced pancreatic cancer: up-regulation of thymidine phosphorylase. Cancer J. 2007;13:247–256
  14. Goldstein D, Van Hazel G, Walpole E, et al. Gemcitabine with a specific conformal 3D 5FU radiochemotherapy technique is safe and effective in the definitive management of locally advanced pancreatic cancer. Br J Cancer. 2007;97:464–471
  15. Morganti AG, Valentini V, Macchia G, et al. 5-fluorouracil-based chemoradiation in unresectable pancreatic carcinoma: phase I–II dose-escalation study. Int J Radiat Oncol Biol Phys. 2004;59:1454–1460
  16. Cohen SJ, Dobelbower RJ, Lipsitz S, et al. A randomized phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern Cooperative Oncology Group study E8282. Int J Radiat Oncol Biol Phys. 2005;62:1345–1350
  17. Lind PA, Isaksson B, Almstrom M, et al. Efficacy of preoperative radiochemotherapy in patients with locally advanced pancreatic carcinoma. Acta Oncol. 2008;47:413–420
  18. Chauffert B, Mornex F, Bonnetain F, et al. Phase III trial comparing intensive induction chemoradiotherapy (60Gy, infusional 5-FU and intermittent cisplatin) followed by maintenance gemcitabine with gemcitabine alone for locally advanced unresectable pancreatic cancer. Definitive results of the 2000–01 FFCD/SFRO study. Ann Oncol. 2008;19:1592–1599
  19. Small W, Berlin J, Freedman GM, et al. Full-dose gemcitabine with concurrent radiation therapy in patients with nonmetastatic pancreatic cancer: a multicenter phase II trial. J Clin Oncol. 2008;26:942–947
  20. Chengiz M, Zorlu F, Yalcin S, et al. Concurrent gemcitabine and radiotherapy for locally advanced pancreatic cancer. Med Oncol. 2007;24:239–243
  21. Kurt E, Kurt M, Kanat O, et al. Phase II study of induction chemotherapy with gemcitabine plus 5-fluorouracil followed by gemcitabine-based concurrent chemoradiotherapy for unresectable locally advanced pancreatic cancer. Tumori. 2006;92:481–486
  22. Shinchi H, Takao S, Noma H, et al. Length and quality of survival after external-beam radiotherapy with concurrent continuous 5-fluorouracil infusion for locally unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2002;53:146–150
  23. Boeck S, Hoehler T, Seipelt G, et al. Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx): final results of a multicenter randomized phase II trial in advanced pancreatic cancer. Ann Oncol. 2008;19:340–347
  24. Nehls O, Oettle H, Hartmann JT, et al. Capecitabine plus oxaliplatin as first-line treatment in patients with advanced biliary system adenocarcinoma: a prospective multicentre phase II trial. Br J Cancer. 2008;98:309–315
  25. Krishnan S, Rana V, Janjan NA, et al. Induction chemotherapy selects patients with locally advanced, unresectable pancreatic cancer for optimal benefit from consolidative chemoradiation therapy. Cancer. 2007;110:47–55
  26. Reni M, Cereda S, Balzano G, et al. Carbohydrate antigen 19-9 change during chemotherapy for advanced pancreatic adenocarcinoma. Cancer. 2009;115:2630–2639
  27. Hess V, Glimelius B, Grawe P, et al. CA19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial. The Lancet Oncol. 2008;9:132–138
  28. Wong D, Ko AH, Hwang J, et al. Serum CA19-9 decline compared to radiographic response as a surrogate for clinical outcomes in patients with metastatic pancreatic cancer receiving chemotherapy. Pancreas. 2008;37:269–274
  29. Locker GY, Hamilton S, Harris J, et al. ASCO 2006 of recommendations for the use of tumour markers in gastrointestinal cancer. J Clin Oncol. 2006;24:5313–5327

PII: S0167-8140(10)00230-6

doi: 10.1016/j.radonc.2010.04.004

Radiotherapy & Oncology
Volume 95, Issue 3 , Pages 292-297 , June 2010